COMPLETED

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Official Title

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Quick Facts

Study Start:2022-12-22
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05542381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.
  1. * Dementia
  2. * Report baseline eye pain
  3. * Use topical NSAIDs or steroids
  4. * Patient under 18 years old
  5. * History of corticosteroid responsive elevation in intraocular pressure
  6. * Allergy to Loteprednol or Nepafenac
  7. * Pre-existing chronic pain disorders
  8. * Advanced Glaucoma
  9. * Herpes zoster
  10. * Allergy to local anesthetic or penicillin
  11. * Patients unable to consent on own behalf
  12. * Patients unable to communicate pain
  13. * Pregnancy
  14. * Incarceration

Contacts and Locations

Principal Investigator

Vishak John, MD
PRINCIPAL_INVESTIGATOR
Vistar Eye Center
Romulo Albuquerque, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Vistar Eye Center

Study Locations (Sites)

Vistar Eye Center
Roanoke, Virginia, 24019
United States

Collaborators and Investigators

Sponsor: Virginia Polytechnic Institute and State University

  • Vishak John, MD, PRINCIPAL_INVESTIGATOR, Vistar Eye Center
  • Romulo Albuquerque, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Vistar Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • Loteprednol
  • Loteprednol Etabonate Ophthalmic Suspension
  • Immunosuppressive Agents
  • Glucocorticoids
  • Immunologic Factors
  • Molecular Mechanisms of Pharmacological Action
  • Eye Diseases
  • Retinal Diseases
  • Anti-Inflammatory Agents
  • vascular endothelial growth factor
  • Intravitreal Injection
  • Post-Intravitreal Injection Pain

Additional Relevant MeSH Terms

  • Age-Related Macular Degeneration